B.01__PWS_In-Silico_Screening-(Base).pdf

PERFORMANCE WORK STATEMENT

Contents

1. INTRODUCTION

2. PURPOSE AND BACKGROUND

3. SCOPE

4. PERIOD OF PERFORMANCE

5. WORK SCHEDULE AND LOCATION

6. PERFORMANCE REQUIREMENTS

7. DELIVERABLES

8. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

9. TRANSITION SUPPORT

10. KEY PERSONNEL

11. SUPPLIES

12. TRAVEL/TEMPORY DUTY (TDY)

13. GOVERNMENT FURNISHED PROPERTY

14. CONTRACT MANAGEMENT

15. COMPLIANCE DOCUMENTS

16. REFERENCE DOCUMENTS

17. OTHER TERMS, CONDITIONS, AND PROVISIONS

18. ATTACHMENTS

PWS

PERFORMANCE WORK STATEMENT (PWS)

Title: In-silico Screening for Drug Discovery

Requiring Activity Name: Walter Reed Army Institute of Research (WRAIR)

1. INTRODUCTION

The WRAIR aims to conduct biomedical research that is responsive to Department of Defense (DoD) and US Army requirements and delivers life-saving products including knowledge, technology and medical material that sustain the combat effectiveness of the Warfighter.

With our headquarters dedicated to Senator Daniel E. Inouye and located in Silver Spring, Maryland, the Walter Reed Army Institute of Research is the largest biomedical research facility currently serving the Department of Defense.

Established in 1893, our research and development now reaches around the world from Maryland to Germany, Thailand, and Kenya.

Our vision is to be the premier DoD biomedical research organization, constantly relevant, integrating basic research and advanced technology that protects, projects, and sustains the Warfighter today, invents global medical solutions for the future, and keeps the Warfighter on point for the Nation. We host two Centers of Excellence for Military Psychiatry and Neuroscience Research and for Military Infectious Disease Research, each center ranging from blast induced neurotrauma to malaria vaccine development.

2. PURPOSE AND BACKGROUND

The Wound Infections Department (WID) within the Bacterial Diseases Branch (BDB) at WRAIR conducts research to defeat combat-related wound infections. WID conducts requirements-driven programmatic research using a multi-disciplinary approach to characterize wound pathogenesis and develop novel antimicrobial countermeasures for wound infections of Service Members. The WID includes the WRAIR X-ray Crystallography Center, which provides structure-based drug design services to WRAIR, DoD labs, industry, and academic collaborators to support the development of therapeutic and prophylactic countermeasures against bacteria, parasites, and viruses.

3. SCOPE

This Performance Work Statement (PWS) defines the procurement of the technical expertise and support services necessary to perform in-silico screening of commercially available database(s) for novel small- molecule drug discovery, docking of drug candidates into protein targets, and performing molecular modeling in support of the WID, BDB, WRAIR. The contractor shall secure the provisions necessary to meet WID objectives and perform the tasks described in this PWS. To meet the objectives, the contractor shall identify novel small-molecule drug candidates that may inhibit the function of the protein targets, model drug candidates bound to the protein targets, and perform molecular modeling for drug candidate enhancement.

4. PERIOD OF PERFORMANCE

The periods of performance for this contract are as follows:

Base period 28 September 2019 – 27 September 2020 Option period 1 28 September 2020 – 27 September 2021 Option period 2 28 September 2021 – 27 September 2022 Option Period 3 28 September 2022 – 27 September 2023 Option Period 4 28 September 2023 – 27 September 2024

5. WORK SCHEDULE AND LOCATION

5.1. Work Location

The work location is at the contractor site.

5.1.1. Telecommuting

Not applicable for this requirement.

5.1.2. Working During Emergency Situations

5.1.3. Force Protection Condition Info

5.2. Federal Holidays

5.2.1. The contractor shall not perform services on days designated as a Federal Holiday by Federal

Status, Executive Order, Presidential Proclamation or Installation Commander

5.2.2. Federal holidays are an exception to the regular duty hours. Any of the holidays listed below falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. The following is a list of legal federal holidays that services shall not be performed

The following are Federal Holidays:

New Year’s Day Birthday of Martin Luther King, Jr.

Washington’s Birthday Memorial Day Independence Day

Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

5.3. Post Closure

5.4. Work Schedule

The contractor shall provide support from 0745 to 1630 Eastern Time.

6. PERFORMANCE REQUIREMENTS

6.1. Objectives

6.1.1. The Contractor shall perform in-silico screening of commercially available chemical databases using the crystal structures of bacterial therapeutic targets and malaria (parasite) therapeutic targets, provided by the COR, to identify potential drug candidates.

6.1.2. The Contractor shall perform molecular modeling to study the protein: hit compound interaction and integrate biological, chemical, and structural data for each of the therapeutic target compounds.

6.2. Specific Tasks / Requirements

6.2.1. The Contractor shall perform in-silico screening of commercially available chemical databases using the crystal structures of bacterial therapeutic targets and malaria (parasite) therapeutic targets, provided by the COR, to identify potential drug candidates.

6.2.2. Perform Molecular Modeling Studies:

6.2.2.1. The Contractor shall perform molecular modeling to study the protein:hit compound interaction. The COR shall provide the contractor crystal structures of bacterial therapeutic targets and malaria (parasite) therapeutic targets.

6.2.2.1.1. The contractor shall use the crystal structures of therapeutic targets to perform insilico screening of 0.5 million compounds per week and provide structures of high scoring compounds within 1 week after identification (Deliverable 1).

6.2.2.2. The contractor shall deliver modifications to lead compounds within one month after identification (Deliverable 2).

6.2.2.3. The contractor shall purchase and deliver samples of at least 25 top scoring compounds (1-10 mg each) for in vitro testing and co-crystallization experiments within 1 week after identification, or up to a month if synthesis is also required (Deliverable 3).

6.2.2.4. The contractor shall deliver suggested mutations to proteins and vaccine candidates to the COR within 1 week of identification (Deliverable 4).

6.2.3. The contractor shall have Linux operating systems or Mac OS X, available for government use, to process structural data and determine structures.

6.2.3.1. The contractor shall have Linux operating systems or Mac OS X for running x-ray structure refinement programs in PHENIX and able to write computer scripts such as PERL, Linux batch script, and commercial molecular simulations software.

6.2.3.2. The contract shall provide technical/functional support to the COR for data processing using the Linux computer cluster (network of computers to be used for refining structures) (Deliverable 5).

6.2.4. The contractor shall be located within 50 miles of WRAIR, in order to meet with the COR on a weekly basis or as needed.

6.2.4.1. The contractor shall provide the COR with access to the contractor’s off-site Linux cluster to refine the x-ray crystal structures of potential therapeutic targets bound to drug hits on a frequent basis.

6.2.4.2. The contractor shall provide approximately 5 drug hits per week to the COR so that these crystals may be grown in complex with the drugs, and co-crystal datasets may be analyzed (Deliverable 6).

6.2.4.3. The contractor shall provide the COR with access to the contractor location twice a week to process data using the Linux cluster, in order to further refine the co-crystal structure.

6.2.5. The contractor shall deliver a quarterly progress report describing all work done in support of this PWS by the 5th day of the month (Deliverable 7).

6.2.5.1. The report shall include the in-silico screening results and the identity of the top 100 compounds based on energy minimization scoring.

6.2.5.2. The report shall include the selection requirements (how pharmacophores were developed for screening, molecular weight range, logP values, number of rotatable bonds, etc.), structures of compound leads, modifications to lead compounds, and suggested mutations to proteins

6.2.5.3. Reports are due in March, June, September and December of each performance period.

6.2.5.4. The report shall be written using the format outlined in Contract Data Requirements List

(CDRL) Exhibit A, Data Item Description (DID) DI-MISC-80711A.

6.3. Management Reports and Plans

Quality Control Plan (Deliverable 8). The contractor shall provide a draft Quality Control Plan (QCP) no later than (NLT) 15 days after contract award. The contractor shall prepare and adhere to a QCP describing how the contractor intends to manage the contract to achieve the established standards set forth in the Performance Standards Summary Matrix and the contractor’s QCP. At a minimum, the QCP must include a self-inspection plan, an internal staffing plan, and an outline of the procedures that the Contractor will use to maintain quality, timeliness, responsiveness, and customer satisfaction.

Contract Manpower Reporting Application (CMRA) (Deliverable 9). This is a mandatory requirement IAW

Army Federal Acquisition Regulation Supplement (AFARS) 5137.91, Accounting for Contract Services.

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the WRAIR via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address:

http://www.ecmra.mil.

Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2013. Contractors may direct questions to the help desk at:

http://www.ecmra.mil/.

The contractor shall register under the "All Other Defense Components" module. The WRAIR Unit Identification Code (UIC) is W03KAA.

Contractor Performance Assessment Reporting System (CPARS). A CPAR assesses a contractor's performance and provides a record, both positive and negative, on a given contractor during a specific period of time. Each assessment is based on objective facts and supported by program and contract management data, such as cost performance reports, customer comments, quality reviews, technical interchange meetings, financial solvency assessments, construction/production management reviews, contractor operations reviews, functional performance evaluations, and earned contract incentives. Performance evaluations are transmitted into the Past Performance Information Retrieval System (PPIRS) which is used by government agencies to assess contractor past performance for future acquisitions.

The contractor shall appoint a Contractor Representative (CR) and provide this information to the Contracting Officer (KO) within 10 calendar days of award. The contractor POC shall have the authority to comment on the CPAR assessment on behalf of their company and within the timeframes established.

A CPARS assessment must be completed within 120 calendar days after the evaluation. Evaluations are sent to PPIRS within 14 calendar days after the government Assessing Official (AO) has submitted the rating. If the CR has not concurred/non- concurred with the rating, PPIRS will show the government evaluation as "Contractor Comment Pending Review". The CR has a total of 60 calendar days to concur/non- concur with the assessment.

After 60 days, the CR can either concur/non-concur (Deliverable 10). The CR has the authority to: access the Government evaluation; review/comment/concur or non-concur with the assessment within 60 calendar days after notification of the government's assessment. The CR has the right to request a meeting (in writing) with the government within 7 calendar days of notification of an assessment. Once the government and the CR complete the evaluation; an automatic update will be sent to PPIRS and visible for Source Selection. If the CR fails to respond within 60 days, the assessment will be finalized. Training for CPARS can be found on the CPARS website: https://www.cpars.gov/index.htm.

To access CPARS, the contractor must have a Public Key Infrastructure (PKI). It is suggested an ECA certificate of Medium Assurance should be purchased. This should be a Department of Defense identity certificate, not an e-mail certificate.

7. DELIVERABLES

The contractor shall complete and submit deliverables in accordance with the “Deliverables Table” below. Unless specified in the PWS within the description of the deliverable, all deliverables will be made to the COR electronically.

DELIVERABLES TABLE

PWS

Ref.

Number Title/Description Due

6.2.2.

1.1

Deliverable 1 In-silico Derived Compound Structures The contractor shall provide structures of high

Within 1 week after identification scoring compounds within 1 week after identification.

6.2.2.

Deliverable 2 Modifications to Lead Compounds The contractor shall deliver modifications to lead compounds.

Within 1 month after identification

Deliverable 3 Top Scoring Compound Samples The contractor shall purchase and deliver samples of at least 25 top scoring compounds (1-10 mg each) for in vitro testing and co-crystallization experiments

1 week, and NLT 1 month (if synthesis also required), after identification

Deliverable 4 Mutations to Proteins and Vaccine Candidates The contractor shall deliver suggested mutations to proteins and vaccine candidates for enhanced (or decreased) function.

Within 1 week after identification

6.2.3.

Deliverable 5 Technical/Functional Support The contract shall provide technical/functional support to the COR for data processing using the Linux computer cluster

As needed

6.2.4.

Deliverable 6 Drug Hits The contractor shall provide approximately 5 drug hits per week to the COR

Weekly

6.2.5

Deliverable 7 Quarterly Progress Report The contractor shall deliver a quarterly progress report describing all work done in support of this PWS, using the format outlined in CDRL Exhibit

A, DID DI-MISC-80711A.

5th day of December, and then quarterly thereafter

6.3 Deliverable 8 Quality Control Plan NLT 15 days after

contract award

6.3 Deliverable 9 Contract Manpower Reporting Application

The contractor shall complete and deliver the

CMRA.

By October 31 or on the last day of contract performance – whichever is first.

6.3 Deliverable 10 CPAR Concurrence/Non-concurrence

The contractor shall provide concurrence or non-concurrence with the CPARS assessment.

60 calendar days after Government evaluation

7.1. Reports and Documents

Reports and documents delivered by the contractor in the performance of this contract shall be considered Technical Data as defined in the applicable DFAR clause 252.227-7013, Rights in Technical Data- Noncommercial Items. All documentation shall reflect the latest version of the work product or activity, unless specifically directed otherwise by the Government. All documentation shall be prepared in accordance with (IAW) standard industry practices, ensuring electronically produced documents which reflect logical flow of material, tables of contents indexes and page numbering. Where applicable, the contractor’s attention is called to the availability of commercial, industry, federal, and military guides, instructions, and standards for many of the topics addressed in this PWS and under this contract.

Contractor Performance Assessment Reporting System (CPARS). The Contractor CPARS is the DoD mandatory system to electronically capture assessment data and manage the evaluation process. CPARS is used to assesses a Contractor’s performance and provide a record, both positive and negative, on a given contract during a specific period of time. The CPARS process is designed with a series of checks and balances to facilitate the objective and consistent evaluation of Contractor performance. Both Government and Contractor program management perspectives are captured on the CPAR form and together make a complete CPAR. Once the Assessing Official completes the proposed assessment for the period of performance, the CPARS is released to the appropriate Government Contractor Representative for their review and comments. User ID and password will be provided to the designated Government Contractor Representative upon issuance of a task order. The Contractor has 30 days after the Government's evaluation is completed to comment on the evaluation. The Government Contractor Representative must either concur or non-concur to each CPAR. If the Contractor concurs with the proposed assessment and the Reviewing Official does not wish to see the CPAR, the Assessing Official may close out the CPAR. Otherwise, they must forward the CPAR to the Reviewing Official for them to review, enter comments if appropriate, and close out. The Reviewing Official may at their option direct the Assessing Official to forward every CPAR to them for review.

7.2. Inspection and Acceptance

The COR delegated oversight of specific technical, functional and oversight responsiblities is responsible for inspection and acceptance of all services, incoming shipments, documents, and services.

Certification by the Government of satisfactory services provided is contingent upon the Contractor performing in accordance with the performance standards contained in the Performance Work Statement and all terms and conditions of this order, including all modifications.

7.3. COR Information

To be determined upon award.

8. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the Contractor’s performance in relation to performance objectives. The Government will finalize the QASP immediately following award, and the COR will provide a copy of the final QASP to the contractor. The QASP is a living document and may be updated by the Government as necessary.

The Government will use the following performance requirements to measure the performance of the contractor. The contractor shall meet the Performance Objective(s) and Acceptable Quality Level(s) within the “Performance Requirements Summary Matrix” (PRS Matrix).

Performance Requirements Summary Matrix

# PW

S Ref.

Performance Objective Performance Measurement

Acceptable Quality Level

Method of Surveillance Incentive

1 6.2.3 6.2.3 .1

Operating System Requirement The contractor shall have Linux operating systems or Mac OS X, capable of performing the tasks outlined in this PWS, including writing computer scripts such as PERL, Linux batch script, and commercial molecular simulations software

Contractor shall possess the required operating systems to perform the tasks set forth in this PWS; calculated by percentage of tasks completed

Meets: 100%.

Does Not Meet: <100%

Direct observation by

COR

Frequency: As needed

Past Performance

2 6.2.3 .2

Technical and Functional Support The contractor shall possess the technical capability to provide support to the COR in the use of Linux computer cluster

Contractor shall possess the technical knowledge to support the COR in all tasks set forth in this PWS; calculated by number of complaints by

COR

At most 1 complaint per period of performance

Direct observation by

COR

Frequency:

Annual

Past Performance

3 6.2.4

Location and Accessibility The contractor shall be

Contractor shall be available for all in-person meeting requested by

At most 1 missed meeting per month

Direct observation by

COR

within 50 miles of WRAIR to meet in-person with the COR

COR

Frequency:

Monthly

4 6.2.4 .1 6.2.5 .2

Operating System Accessibility The contractor shall provide the COR with access to the contractor location to process data using the Linux cluster, in order to further refine the co-crystal structure.

Contractor operating system shall be available at requested of COR

At most 1 incident of unavailability per quarter

Direct observation by

COR

Frequency:

Quarterly

Past Performance

5 17.1 1.1

Installation Access - Contractor shall follow installation access procedures.

Sum of all incidents in which contractor personnel did not follow installation access procedures

< 1 incident per month

Direct observation by

COR and installation security.

Past Performance

6 17.1 1.5

OPSEC SOP –

Contractor shall submit OPSEC SOP that meets minimum quality standards.

Number of calendar days after contract award that the contractor submits the OPSEC SOP to the COR

< 90 calendar days after contract award

COR receipt of

OPSEC SOP

9. TRANSITION SUPPORT

9.1. Incoming Transition Plan

Not applicable to this requirement.

9.2. Outgoing Transition Plan

Not applicable to this requirement.

10. KEY PERSONNEL

11. SUPPLIES

The contractor shall purchase and deliver samples of at least 25 top scoring compounds (1-10 mg each) for in vitro testing and co-crystallization experiments.

12. TRAVEL/TEMPORY DUTY (TDY)

It is the contractor’s responsibility to cover travel costs to meet with the COR in order to deliver 25 top scoring compounds to the COR.

13. GOVERNMENT FURNISHED PROPERTY

14. CONTRACT MANAGEMENT

14.1. Government Management

The Contracting Officer’s Representative (COR) for this contract will be appointed by the Contracting Officer (KO). The COR will serve as the primary point of contact for all activities and issues that occur under this contract.

Only the KO has the authority to enact changes to this award.

14.2. Contractor Management

The contractor shall designate a single Program Manager (PM) to be the contractor’s authorized point of contact (POC) with the COR. The PM will be responsible for formulating and enforcing performance standards, assigning contractor schedules, reviewing performance quality, communicating policies, purposes, and goals to subordinates. This will include coordination with the KO and the COR to resolve any issues that may arise, trends relating to the contract, or proposed changes or modifications to the contract.

14.3. Contractor Organization

The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The contractor shall ensure that all contractor personnel are advised of their chain of command and who they should contact if they have questions.

14.4. Contractor Vacant Positions

The contractor shall fill vacant positions within thirty (30) business days. If contractor positions are vacant for more than thirty (30) days, the COR will provide a Contract Deficiency Report (CDR) to the KO.

14.5. Subcontract management

14.5.1. The contractor is responsible for any subcontract management necessary to integrate services performed on this contract.

14.5.2. The contractor is responsible and accountable for subcontractor performance on this contract

14.5.3. The contractor is responsible to manage task distribution to ensure there are no OCI considerations

14.5.4. Contractor may add subcontractors to their team after notification and written approval from the KO.

14.5.5. Privy of contract is with the contractor and the subcontractor.

14.6. Foreign Nationals

A foreign national can only be hired if they have a special skill that a US Citizen cannot be found to perform.

A background investigation must be completed in its entirety before unescorted access to the facility is granted. Government computer access will not be approved until a background check is done in accordance with para 18.9. Typically, a background check cannot be performed on a foreign national unless the individual has lived in the United States for three (3) of the last five (5) years.

15. COMPLIANCE DOCUMENTS

15.1. General Compliance

15.1.1. Federal Law

The services provided under this contract must be conducted in accordance with all Federal law, Department of Defense (DOD), Department of the Army (DA) and Medical Research and Material Command (USAMRMC) laws and command laws, regulations, policies, and procedures that govern the conduct of regulated research.

Federal regulations governing regulations for human subject’s protection are found in 45 CFR 46. The International Convention on Harmonization Guidelines for Good Clinical Practice is the standard governing the conduct of research trials. References for military regulations and policies governing regulated research may be found at https://mrmc.amedd.army.mil/rodorphrpo.asp.

15.1.2. DoD Compliance Documents

A complete list of Department of Defense compliance documents providing specifications, standards, or guidelines can be found at http://www.dtic.mil/whs/directives/corres/dir.html

A complete list of Department of Defense compliance documents providing specifications, standards, or guidelines can be found at http://www.dtic.mil/whs/directives/corres/dir.html

a) Army Regulation 340-21, Army Privacy Program.

http://www.army.mil/usapa/epubs/340_Series_Collection_1.html

b) Army Regulation 25-1, Information Technology.

http://armyhpubs.army.mil/epubs/25_Series_Collection_1.html

c) Army Regulation 25-2, Information Assurance.

d) Department of Defense (DoD) Instruction 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research, dated November 2011.

http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf

e) Department of Defense (DOD) 6025.18 Regulation, DOD Health Information Privacy Regulation, 24 January 2003.

f) DOD Instruction 3210.7, Research Integrity and Misconduct, 14 May 2004.

g) Department of Defense (DOD) Instruction 8500.01 Cybersecurity

h) Department of Defense (DOD) Instruction 8510.01 Risk Management Framework (RMF) For DOD Information Technology (IT Department of Defense (DoD) Instructions 5400.11-R, Privacy Program http://www.dtic.mil/whs/directives/corres/pdf/540011p.pdf

i) Army Regulation (AR) 70-25: Use of Volunteers as Subjects of Research, Headquarters, Department of the Army, dated 25 January 1990 – currently under revision

j) Clinical Laboratory Improvement Amendments, 2013. https://www.cms.gov/Regulations-and- Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html. Specific guidance: http://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5

k) Clinical Laboratory Improvement Program (CLIP) Manual, May 29, 2014.

http://www.dtic.mil/whs/directives/corres/pdf/64402m.pdf (this document is codified Title 42 Part 493 under Memorandum of Agreement between the US Department of Defense and Health and Human Services.

l) College of American Pathologists Inspection Checklists. http://www.cap.org

m) Clinical Laboratory Standards Institute. Standards and Guides for Laboratories:

http://clsi.org/standards

n) Title 42 Part 493 Laboratory Requirements, 1 October 2011 https://www.gpo.gov/fdsys/granule/CFR-2011-title42-vol5/CFR-2011-title42-vol5-part493/content-detail.html

o) National Institutes of Allergy and Infectious Diseases, DAIDS Guidelines for Good Clinical

Laboratory Practice Standards, https://www.niaid.nih.gov/LabsAndResources/resources/DAIDSClinRsrch/Documents/gclp.pdf

p) ICH Guideline for Good Clinical Practice, Consolidated Practice (E6) http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html

q) Title 21, CFR Part 11 Electronic Records: Electronic Signature.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

r) Title 21 CFR Part 56, Institutional Review Boards https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56

s) Title 21 CFR Part 812, Investigational Device Exemptions, April 1, 2014 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=812

t) Title 29 Part 1910.1030 Bloodborne Pathogens; 1910.1200, Hazard Communication; 1910.132 Personal Protective Equipment https://www.osha.gov/pls/oshaweb/owastand.display_standard_group?p_toc_level=1&p_part_nu mber=1910

u) Title 42 CFR 72.3 Transportation of Materials Containing Certain Etiologic Agents; Minimum

Packaging Requirements. https://www.gpo.gov/fdsys/granule/CFR-2007-title42-vol1/CFR-2007-title42-vol1-sec72-3

v) Title 49 CFR Part 173.199 Category B Infectious Substances https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol2/pdf/CFR-2015-title49-vol2-sec173- 199.pdf

w) Dangerous Goods Regulations of the International Air Transport Association.

http://www.iata.org/Pages/default.aspx

x) Title 5, U.S.C section 5A, Records Maintained on Individuals https://www.gpo.gov/fdsys/granule/USCODE-2010-title5/USCODE-2010-title5-partI-chap5-subchapII-sec552a/content-detail.html

15.2. Information Technology Compliance

15.2.1. Army Regulation 25-1, Information Technology

Compliance information regarding Army Information Technology may be found at:

http://armyhpubs.army.mil/epubs/25_Series_Collection_1.html

15.2.2. Army Regulation 25-2, Information Assurance

Compliance information regarding Army Information Assurance may be found at:

https://ia.signal.army.mil/docs/AR25-2.pdf

15.2.3. Cyber-security

15.2.3.1. Federal Law

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) The Federal Information Security Management Act (FISMA) The E-Government Act of 2002

15.2.3.2. Office of Management and Budget (OMB)

The following publications are located at https://www.whitehouse.gov/omb/agency/default Circular A-130 Guidance M-05-24, Implementation of Homeland Security Presidential Directive

(HSPD) 12-Policy for a Common Identification Standard for Federal Employees and Vendors

15.2.3.3. National Institute of Standards and Technology (NIST)

The following publications are located at http://www.nist.gov/publication-portal.cfm NIST Special Publication (SP) 800-37 – Guide for Applying the Risk Management

Framework (RMF) to Federal Information Systems NIST SP 800-53 – Security and Privacy Controls for Federal Information Systems and

Organizations

15.2.3.4. Federal Information Processing Standards (FIPS)

The following publications are located at http://www.nist.gov/itl/fipscurrent.cfm FIPS Publication (FIPS PUB) 140-2, Security Requirements for Cryptographic Modules FIPS PUB 199 – Standards for Security Categorization of Federal Information and

Information Systems FIPS PUB 201-2, Personal Identity Verification of Federal Employees and Vendors

15.2.3.5. Department of Defense (DoD)

The following publications are located at http://www.dtic.mil/whs/directives/ DoD Instruction 5200.2, DoD Personnel Security Program (PSP) DoD Instruction 8500.1, Cybersecurity DoD Instruction 8520.02, Public Key Infrastructure (PKI) and Public Key (PK)

Enabling DoD Instruction 8510.01, Risk Management Framework Process (RMF) DoD Instruction 8551.1, Ports, Protocols, and Services Management (PPSM) DoD Instruction 8580.02, Security of Individually Identifiable Health Information in

DoD Health Care Programs DoD Instruction 6025.18, Privacy of Individually Identifiable Health Information in

DoD Health Care Programs

DoD Directive 5400.11, DoD Privacy Program DoD Manual 5400.11-R, Department of Defense Privacy Program

15.2.4. Risk Management Framework

Department of Defense (DOD) Instruction 8510.01 Risk Management Framework (RMF) For DOD Information Technology (IT Department of Defense (DoD) Instructions 5400.11-R, Privacy Program http://www.dtic.mil/whs/directives/corres/pdf/540011p.pdf

16. REFERENCE DOCUMENTS

a) Department of Defense Directive 6485.01, Human Immunodeficiency Virus, June 7, 2013.

http://www.dtic.mil/whs/directives/corres/pdf/648501p.pdf

b) Department of Defense Instruction 6440.02, Clinical Laboratory Improvement Program (CLIP) Manual, May 29, 2014. http://www.dtic.mil/whs/directives/corres/pdf/644002p.pdf

c) Department of Defense Instruction 3216.02, Protection of Human Subjects and Adherence to Ethical Standard in D00D-Supported Research. http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf

d) Army Regulation 600-110, Identification, Surveillance, and Administration of Personnel Infected with Human Immunodeficiency Virus, 22 April 2014. http://www.apd.army.mil/pdffiles/r600_110.pdf

e) Army Regulation 40-501, Standards of Medical Fitness

f) US Medical Entrance Processing Command Regulation 40-1, Medical Processing and Examinations http://www.mepcom.army.mil/ASP/pubnform.asp?topic=Regulations&sort=pubNo

g) US Medical Entrance Processing Command Regulation 40-8, Department of Defense (DOD) Human Immunodeficiency Virus (HIV) Testing Program and Drug and Alcohol Testing (DAT) Program http://www.mepcom.army.mil/ASP/pubnform.asp?topic=Regulations&sort=pubNo

17. OTHER TERMS, CONDITIONS, AND PROVISIONS

17.1. Non-Personal Services

This PWS identifies services that are strictly non-personal in nature, as defined by Federal Acquisition Regulation (FAR) Part 37, Service Contracting. To ensure there is no appearance of any personal services, the Government shall neither supervise contractor personnel nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks or prepare work schedules for individual contractor personnel. It shall be the responsibility of the contractor to manage its personnel and to guard against any actions that give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the Contractor Officer (KO) immediately.

17.2. Severable / Non-Severable Services

This award identifies services that are severable in nature.

17.3. Inherently Governmental Functions

This requirement has been reviewed and contains no services that are inherently governmental functions.

17.4. Acquisition Functions Closely Associated with Inherently Governmental Functions

Not applicable for this award.

17.5. Organizational Conflict of Interest

Walter Reed Army Institute of Research (WRAIR) has categorized its requirements into two broad categories, as defined below, for purposes of identifying, avoiding or mitigating against OCIs in accordance with FAR Subpart 9.5. These categories apply to all enterprise laboratories AFRIMS, USAMRD-A, and USAMRD-G.

These categories are defined as follows:

Global Support: Where services which, by their very nature, give the Contractor access to non-public procurement sensitive data about the contract requirements, other contractors’ proprietary information, or put the contractor in a position to influence the award decision on a contract in which they are participating.

These services are identified as those having a direct impact to the operations of the greater WRAIR enterprise.

Services would be characterized as having access to Command Wide procurement sensitive information, or work that could likely have an influence over follow-on awards or contracts within subordinate directorates/Commands.

Mitigation strategies may include: avoidance (non-participation), firewalls between existing personnel and new requirement.

Isolated Support: Services which have focused impact on a specific Branch/ Department/ Program of WRAIR rather than the WRAIR enterprise.

Services can be characterized as having little or no access to procurement sensitive information other than the immediate requirement and little chances of follow-on work that can be influenced by the immediate requirement.

Mitigation Strategies: Contractor can provide a mitigation plan or acceptable self-certification that no OCI exists.

Contractor participation in more than one of these areas may give rise to an unfair competitive advantage resulting from access to advance acquisition planning, source selection sensitive or proprietary information.

Furthermore, Contractor participation in more than one area may give rise to a real or apparent loss of Contractor impartiality and objectivity where its advisory or planning assistance in one area potentially affects its present or future participation in another area.

The purpose of this categorization is to accomplish the following three objectives: (1) to inform prospective Offerors that WRAIR presumes that award of a contract or order in the subject category will give rise to real or apparent OCI’s with respect to requirements in the other category and or may give rise to an OCI in the same category; (2) to assist current Contractors and prospective Offerors in developing their own business strategies regarding participation in WRAIR requirements and in identifying and, where possible, avoiding or mitigating against OCIs; and (3) to ensure that all current Contractors and prospective Offerors are afforded the maximum practicable opportunity to compete for all WRAIR requirements consistent with the restrictions required under FAR Subpart 9.5 and sound business practices.

For purposes of identifying and/or mitigating against OCIs, WRAIR will examine all its services requirements and acquisitions regardless of the cognizant contracting activity (e.g., USAMRAA, GSA, other agency Multiple Award Schedules, etc.) or the type of contract vehicle used (e.g., FSS order, Fair Opportunity competitive order under Multiple Award ID/IQ Contracts, competitively negotiated awards under FAR Part 15, etc.).

Each WRAIR services solicitation will therefore be designated as falling within one of the above defined categories. The applicable OCI category will be set forth in each award.

This requirement is categorized as ISOLATED SUPPORT.

Organizational and consulting conflicts of interest may arise by performing advisory or consulting support services. Organizational conflicts of interest include providing services or performing advisory or consulting work for private companies that participate or will participate in future services or contract activities (solicitations and award). See FAR subpart 9.5.

The Contractor shall ensure that the Participation Agreement, either A and / or B as identified on each award, is signed by all staff assigned to or performing on each award before performing any work, including all subcontractors and consultants. The Participation Agreement shall be cosigned by a corporate official (contractor Task Manager or higher). The Contractor shall also ensure that all staff understand and adhere to the terms of the non-disclosure statement, protecting the procurement sensitive information of the Government and the proprietary information of other contractors. Assignment of staff who has not executed this statement or failure to adhere to this statement shall constitute default on the part of the Contractor and the COR will immediately initiate a CDR.

17.6. Invoices

The contractor shall submit invoices monthly to Wide Area Work Flow (WAWF) with sufficient documentation to provide certification of invoice.

The contractor is responsible for properly preparing and forwarding to the appropriate Government official, the invoice and receiving report for payment. The contractor shall attach back up information to receiving reports for direct labor and Other Direct Costs (ODCs). Direct labor backup information shall reflect the person’s name, job title and quantity of hours worked for each pay period at a minimum. Backup information for ODCs shall list all elements of costs, such as travel breakout backup, including itinerary, dates of travel, name of employees traveling plus per diem costs shall accompany the receiving report. All ODCs exceeding $3,000 requires that the contractor conduct appropriate competition and obtain approval from the COR prior to purchase. Equipment purchases are not authorized under this contract. The Wide Area Workflow – Receipt and Acceptance application is the required method of submission.

Where applicable, contractor will include additional ODC invoice details as required per protocol for any volunteer payments in support of this PWS.

17.7. Dissemination of Information/Publishing

There shall be no dissemination or publication, except within and between the Contractor and any Sub Contractors or specified Integrated Product/Process Team (IPT) members who have a need to know, of information developed under this order or contained in the reports to be furnished pursuant to this order without prior written approval of the COR or the Contracting Officer.

DFARS 252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting. The contractor shall implement National Institute of Standards and Technology (NIST) Special Publication (SP) 800-171, “Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations.”

17.8. Contractor Identification

The Contractor shall ensure that Contractor personnel identify themselves as Contractors when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts. Contractors may not use or allude to former or current military rank during the performance of this work.

17.9. Attendance at Meetings

Contractor personnel may be required to attend meetings or otherwise communicate with Government and/or other contract or assistance agreement representatives to meet the requirements of this order. Contractor personnel shall make their contractor status known during introductions.

17.10. Data Rights

Contractor shall deliver a Quarterly Technical Report in accordance with DI-MISC-80711A.

17.11. Anti-Terrorism and Operational Security

17.11.1. AT Level I Training.

All contractor employees, including subcontractor employees, requiring access to Army installations, facilities, and controlled access areas shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable.

DFARS 204.7202 Contractor personnel who, as a condition of contract performance, require routine physical access to a Federally-controlled facility or military installation are required to complete Level I antiterrorism awareness training within 30 days of access and annually thereafter.

Include the clause at DFARS 252.204-7004 DoD Antiterrorism Awareness Training for Contractors, in solicitations and contracts, including solicitations and contracts using FAR part 12 procedures for the acquisition of commercial items, when contractor personnel require routine physical access to a Federally-controlled facility or military installation.

The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee to the COR or to the contracting officer, if a COR is not assigned, within 30 calendar days after completion of training by all employees and subcontractor personnel. AT Level I awareness training is available at the following website: http://jko.jten.mil.

17.11.2. AT Awareness Training for Contractor Personnel Traveling Overseas.

17.11.3. iWATCH Training. This standard language is for contractor employees with an area of performance within an Army-controlled installation, facility, or area.

17.11.4. Army Training Certification Tracking System (ATCTS) registration for contractor employees who require access to Government information systems.

17.11.5. For Contracts That Require an OPSEC Standing Operating program.

The contractor shall develop an OPSEC Standing Operating Procedure (SOP)/Plan within 90 calendar days of contract award, to be reviewed and approved by the responsible Government OPSEC officer. This plan will include a process to identify critical information, where it is located, who is responsible for it, how to protect it, and why it needs to be protected. The contractor shall implement OPSEC measures as ordered by the commander. In addition, the contractor shall have an identified certified Level II OPSEC coordinator per AR 530-1.

17.11.6. For Contracts That Require OPSEC Training.

Per AR 530-1, Operations Security, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

17.11.7. For IA/IT training.

17.11.8. For Information Assurance (IA)/Information Technology (IT) Certification.

17.11.9. For Contractors Authorized to Accompany the Force.

17.11.10. For Contract Requiring Performance or Delivery in a Foreign Country.

Not applicable for this requirement.

17.11.11. For Contracts That Require Handling or Access to Classified Information.

Not applicable for this requirement.

17.11.12. Threat Awareness Reporting Program (TARP).

Not applicable for this requirement.

17.12. Personally Identifiable Information (PII) and Protected Health Information (PHI) The contractor shall comply with the DHA Procedures, and Information (PGI) 224 – Protection of Privacy and Freedom of Information, revised 17 May 2015. The contractor may access PII in the course of task response to the requirements of this contract, as such the contractor shall comply with the document entitled “Personally Identifiable Information (PII), Protected Health Information (PHI) and Federal Information Requirements”.

The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Government data. The Contractor shall also ensure the confidentiality, integrity, and availability of Government data in compliance with all applicable laws and regulations, including data breach reporting and response requirements, in accordance with DFAR Subpart 224.1 (Protection of Individual Privacy), which incorporates by reference DoDD 5400.11, “DoD Privacy Program,” May 8, 2007, and DoD 5400.11-R, “DoD Privacy Program,” May 14, 2007. The contractor shall also comply with federal laws relating to freedom of information and records management. The Contractor shall comply with all requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Pub. L. 104-191), as implemented by the HIPAA Privacy and Security Rules codified at 45 CFR Parts 160 and 164, and as further implemented within the Military Health System (MHS) by DoD 6025.18-R, "DoD Health Information Privacy Regulation," January 24, 2003, and DoD 8580.02-R, “DoD Health Information Security Regulation, July 12, 2007.

IT services that collect, maintain, use, or disseminate personally identifiable information must be managed in a manner that protects privacy, in accordance with section 552a of Title 5, U.S.C. (Reference (aa)), DoD 5400.11 (Reference (ab)) and DoD 5400.11-R (Reference (ac)). DoDI 5400.16 (Reference (ad)) established the guidance for development, review, and approval of Privacy Impact Assessments, in accordance with chapter 36 of Title 44, U.S.C. (Reference (ae)).

17.13. Public Key Infrastructure Authentication and Encryption Contractors shall follow the DoD standards, policies, and procedures related to the use of Public Key Infrastructure (PKI) certificates and biometrics for positive authentication including authentication to DoD private web servers or applications. Where interoperable PKI is required for the exchange of unclassified information, including the encryption of e-mail containing sensitive information, between DoD and its Contractors, industry partners shall obtain all necessary certificates if they are not eligible for a DoD Common Access Card. (refer to: http://iase.disa.mil/pki/eca/ and http://www.cac.mil/)

17.14. Network Security

Contractor personnel requiring access to DoD networks to perform work under this contract must have a NACI or an open, pending investigation prior to commencement of work. If the Contractor has a pending investigation, the contractor must present a copy of this investigation to the WRAIR Security Manager at the time of in-processing for review and must contain no unfavorable information. The Contractor must maintain this level of security for the life of the contract. Citizenship will be verified by presenting an original birth certificate or a valid US Passport or the original Naturalization certificate to the WRAIR Personnel Security Manager at the time of in-processing for all contractor personnel assigned to the contract.

Contractor personnel shall use only Government-provided computer equipment; and shall follow all applicable statutes, regulations and policies governing DoD, MEDCOM, USAMRMC, and WRAIR cyber security and information system assets. Personnel must provide proof of applicable training and certifications to include annual Cyber Awareness training. This training must be documented in the Army Training and Certification

Tracking System (ATCTS) unless otherwise authorized by applicable policies. DoD Information System, IT service, and IT product acquisition or development must also adhere to applicable policies as described below:

17.14.1. It is DoD policy that Cybersecurity requirements shall be identified and included in the design, acquisition, installation, operation, upgrade, or replacement of all DoD information systems. This includes systems and processes developed within the Defense Acquisition System; systems and processes developed at private expense; outsourced business processes supported by private sector information systems; and outsourced information technologies. Information technology services provided under this contract must comply with statutory and regulatory IA policy. The source documents for this policy are (available in the WRAIR regulatory repository for review):

a. The National Security Act of 1947

b. Title 40/Clinger-Cohen Act

c. Executive Order 12333, “United States Intelligence Activities,”

d. National Security Presidential Directive-54/Homeland Security Presidential Directive-23

e. Subchapter III of chapter 35 of Title 44, United States Code (also known as the “Federal

Information Security Management Act (FISMA) of 2002”)

f. National Security Telecommunications and Information Systems Security Policy No. 11, "Revised Fact Sheet National Information Assurance Acquisition Policy" and associated "Frequently Asked Questions"

g. National Institute…